UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024987 |
|---|---|
| Receipt number | R000028751 |
| Scientific Title | Phase II clinical trial of pleurodesis with a 50% glucose solution for persistent air leak after pulmonary resection |
| Date of disclosure of the study information | 2016/11/24 |
| Last modified on | 2017/05/26 14:34:11 |
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Basic information
Public title
Phase II clinical trial of pleurodesis with a 50% glucose solution for persistent air leak after pulmonary resection
Acronym
Phase II clinical trial of pleurodesis with a 50% glucose solution for persistent air leak after pulmonary resection
Scientific Title
Phase II clinical trial of pleurodesis with a 50% glucose solution for persistent air leak after pulmonary resection
Scientific Title:Acronym
Phase II clinical trial of pleurodesis with a 50% glucose solution for persistent air leak after pulmonary resection
Region
| Japan |
Condition
Condition
Postoperative persistent air leak or postoperative pneumothorax after pulmonary resection
Classification by specialty
| Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Treatment for postoperative persistent air leak or postoperative pneumothorax is drainage, pleudolesis or operation. In Japan OK-432 has been used as pleurodesis routinely, however anaphylaxis and acute exacerbation of interstitial pneumonia has been reported as the adverse events. Otherwise the indication for the pleurodesis with OK-432 is for malignant pleural effusion. The drug price is about 7,000 yen and so expensive. Therefore safe and low-cost drug is expected. Pleurodesis with a 50% glucose solution has been reported for several years. The treatment cause hyperglycemia, however it has been reported as the safe and low-cost treatment. On the other hand there is no prospective study about the effect and adverse events and we planed this study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Rate of stopping air leakage after pleurodesis with a 50% glucose solution
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
50% glucose solution group
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Postoperative persistent air leak or postoperative pneumothorax after pulmonary resection
Key exclusion criteria
1) Patients with poor general condition caused by disease such as severe infection
2) Pregnant, breastfeeding , sexually active woman, or patients with no contraception.
3) Patients with severe diabetes mellitus
4) Patients registration to this study is deemed difficult due to mental disorders clinically relevant
5) Considered to be inappropriate for the participation in this study by the investigators
6) Patients unwilling to sign the consent form for participation
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Mizukami |
Organization
Hokkaido Cancer Center
Division name
Department of thoracic surgery
Zip code
Address
2-3-54, Kikusui 4-jo, Shiroishi-ku Sapporo-shi, Hokkaido, 003-0804, Japan
TEL
011-811-9111
mizukami@sap-cc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Mizukami |
Organization
Hokkaido Cancer Center
Division name
Department of thoracic surgery
Zip code
Address
2-3-54, Kikusui 4-jo, Shiroishi-ku Sapporo-shi, Hokkaido, 003-0804, Japan
TEL
011-811-9111
Homepage URL
mizukami@sap-cc.go.jp
Sponsor or person
Institute
Hokkaido Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Hokkaido Cancer Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 10 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 24 | Day |
Last modified on
| 2017 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028751
